Federal Circuit Reluctantly Affirms Ariosa v. Sequenom and Denies En Banc Rehearing

Ariosa v. Sequenom (Fed. Cir. 2015) (en banc petition denied)

The Federal Circuit has denied Sequenom’s petition for en banc rehearing – reconfirming the panel holding that the claimed “method of detecting paternally inherited nucleic acid” is unpatentable as a law of nature.  Patent No. 6,258,540.  Following this case, the USPTO may finally begin applying the law-of-nature exception in a major way. The decision also sets up a petition for writ of certiorari to the Supreme Court with several members of the Federal Circuit expressly calling for review.

As I previously wrote, the invention at issue here solves a very practical problem accessing fetal DNA without creating a major health risk for the unborn child.  The big idea was the hypothesis that fetal DNA might be floating around in the mother’s blood and that the fetal DNA could be selectively amplified by focusing on the paternally inherited portion of its DNA (rather than the maternally inherited).

The claim itself has two simple steps: (1) amplifying paternally inherited DNA from a plasma sample taken from a pregnant female and then (2) detecting the presence of the DNA. As I mentioned, the big idea was understanding where the baby-DNA could be found (in the mother’s blood plama) and that it could be separated from the mother’s DNA by linking it to the father’s sequence. The technology for amplifying and detecting was already well known at the time of the invention here.  Further, these two steps – amplifying and detecting – are the ones always almost used to detect particular DNA sequences.

The district court found the patent invalid under Section 101.  That decision was affirmed by a Federal Circuit panel in an opinion written by Judge Reyna and a concurrence by Judge Linn.  Now, in the 11-1 en banc denial, we add three more opinions – Judge Lourie (joined by Judge Moore) and Judge Dyk, both concurring in the denial as well as Judge Newman dissenting.

The basic controlling precedent in this case is Mayo v. Prometheus. In that case, the Supreme Court held that the discovered therapeutic efficacy and toxicity of a particular administered drug to be an unpatentable natural law and that the patented testing and dosage methods were also unpatentable as effectively claiming the same law of nature. In particular, the court noted that the claimed steps were not “genuine applications of those laws[, but] rather … drafting efforts designed to monopolize the [unpatentable] correlations.” As in Ariosa, the testing and determination steps were well known in the art and relied upon well-understood, routine, and conventional activity known to those in the field. As such, those additional steps were insufficient to transform the unpatentable law of nature into a patent eligible application of the natural law.  

In Ariosa, the Federal Circuit stands almost unanimously in the conclusion that Sequenom’s invention is not patent-eligible under the Mayo precedent (only Judge Newman disagrees).  There is, however, substantial disagreement about whether the Supreme Court was correct in its Mayo analysis.

Judge Dyk: I share the concerns of some of my colleagues that a too restrictive test for patent eligibility under 35 U.S.C. § 101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena. This leads me to think that some further illumination as to the scope of Mayo would be beneficial in one limited aspect. At the same time I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.

Judge Lourie: [I]t is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.

Judge Linn:  In my view, the breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.  (Note, Judge Linn participated in the original panel decision but could not dissent here because of his Senior Status).

It will be interesting to see how this proceeds, but my view is that the case has a low-chance for certiorari.  In Mayo, the Supreme Court indicated its understanding that the case would halt patenting of many diagnostics, but expressly called on Congress to “craft[] more finely tailored rules where necessary.”  In the 3 1/2 years since the Mayo decision, the diagnostic industry has not been able to get a bill even proposed in Congress that would so-tailor these rules (at least that I know of).

 

187 thoughts on “Federal Circuit Reluctantly Affirms Ariosa v. Sequenom and Denies En Banc Rehearing

  1. 15

    Where oh where have all the naysayers gone?

    Is Ned the only one that is willing to speak up (even if he does so to only skirt the issue)….?

    Come people: this is a definitional aspect of patent law. First principles and all that.

    35 U.S.C. 100 (a).

    1. 15.1

      Anon, regarding §100(a), you are arguing that there is a distinction between invention and discovery. I do not disagree. As I said before, I do not believe that one can discover a new machine, manufacture or method. One can however discover a product of nature or a law of nature.

      Were not for the word “new” in the statute that was added by Jefferson in 1793 when he added “composition,” I would agree that discovery of compositions found in nature would be statutorily authorized.

      That leaves the question of laws of nature. What are these but facts? Can one patent a fact? I do not think so. Facts are neither machines, manufactures, methods or compositions. That is why facts cannot be patented.

      But one can patent applications of one’s discoveries. That means one can patent an application of a law of nature or new use for a product of nature.

      Do you have any fundamental problem with this analysis?

      1. 15.1.1

        Ned,

        I very much have a fundamental problem with your analysis.

        Several, in fact.

        First, your “version” of “new” is just that: a version. (and that “version” depends on the wrong branch writing the statutory law)

        Second, you STILL do not actually address the very direct words of 35 USC 100 (a).

        Third, you continue to ig nore the fact that the Act of 1952 is the controlling law on this topic – and not any earlier patent act. You just do not get to act in a vacuum and not take into account that Congress revamped – substantively – the ENTIRE single paragraph to create the panoply of what we now talk about as 101/102/103/112.

        That said, let me give you a direct point and ask (once again) that you treat the direct words of 35 USC 100(a).

        Any “version” you come up with cannot make the direct words of Congress “disappear.”

        Your attempt here to draw a distinction as to ONLY being patent-eligible (you incorrectly use the phrase patentable, perhaps a nit, perhaps not), as to those things that take discoveries and APPLY them. The problem with that position is you are directly reading out of the statute “discoveries.” Your “want” here IS invention. That is already a given, and you are doing nothing more than conflating on the VERY POINT that I am asking you to recognize the need NOT to conflate.

        No one is questioning that an invention that APPLIES discoveries is rightfully belonging to 35 USC et al.

        No one.

        Please STOP trying to use “logic” that arrives at a point that no one is arguing about.

        Please return to the underlying definitional issue that I am explicitly asking about.

        While you contemplate the words of Congress, DO keep in mind the proper congressional authority, and DO NOT attempt to nullify the direct words that I am asking about.

        1. 15.1.1.1

          What are the chances that we will be treated to “crickets” yet again, instead of something directly on point…?

        2. 15.1.1.2

          Anon, Congress did not write on a blank sheet. The words of a statute are interpreted according to the way they were understood when they were enacted.

          1. 15.1.1.2.1

            Ned,

            It simply is NOT a matter of Congress “writing on a blank slate” as you wish to allude to.

            I have been more than clear in showing you that your view just does not match the words of Congress, the congressional record, the writings of Federico and Rich, and even post-1952 case law.

            You, on the other hand, have shown NOTHING but your “version” and your say-so.

            Your “point here” does not even reach, as the understanding at the time of 1952 is abundantly clear that your ‘version” simply cannot hold.

          2. 15.1.1.2.2

            And let me point out (yet again) – that you STILL have not addressed the simple fact of 35 USC 100 (a) as I have set forth.

            Why is this so very difficult for you?

            Remember: use the proper year of congressional authority (1952) and do NOT have a version that eliminates the very words of Congress.

            It should be a clear logical hint to you that if your version does in fact eliminate the words of Congress, that there is something very wrong with your version. Why is it so very hard for your to think critically on this matter?

              1. 15.1.1.2.2.1.1

                Ned,

                Your mere acknowledgment of the point that I have a valid point in that 35 USC 100(a) means that there is a difference between invention and discovery is simply not enough to be able to say that you have addressed that section of law.

                I provided two considerations for you to also meet. You have met neither.

                All that you have done – and exactly as I have described your actions – is to attempt an end game around that very section and a (continued) attempt to peddle a version of law that in fact eliminates the words of Congress.

                Once again Ned, I call on you to address the section of law in a proper manner.

                Take baby steps if you need to. You have admitted to a difference existing. How does discovery go beyond invention (what is the difference in a patent eligible manner).

                All I see from you is a mere “token” answer and dissembling move to your “version” which without more is simply NOT supported by your own admission that a difference exists.

              2. 15.1.1.2.2.1.2

                (still waiting Ned – come to the page, read my counter points and please try to (finally) address the item I ask about (and not your gallivanting into the weeds of some other “version”)

      2. 15.1.2

        So then Ned, you agree that one can patent a method of determining the energy equivalent of a mass based on a discovered fact?

  2. 14

    Dear Ned and the Supremes:

    You may want to rethink the whole “Judical Exception” thing. I mean if methods aren’t methods under 101 if they occur in nature, then the method for making penicillin is not patentable and no one invests in penicillin manufacturing plants.

    1. A method for producing penicillin comprising incubating a pencillin-producing mold in contact with an aqueous nutrient medium containing an assimilable carbon source and containing from 5.0 to g. of degraded proteinaceous material per liter of medium, a portion of the assimilable carbon source being added at the beginning of the incubation period and additional increments thereof being added during the period to compensate for that used up by the mold, the total amount of assimilable carbon source used being from 5.0 to 150 g. per liter of medium.

    link to awesomestories.com

    link to patents.google.com

    1. 14.1

      Les, I do not agree that the lack of eligibility for products of nature is based upon a judicial exception. The Supreme Court held in Myriad that products of nature were not “new” compositions. This is exactly in accord with the way new was added to the 1793 statute when compositions were added. In order to be eligible subject matter, the compositions must be new in an absolute sense even though our otherwise unknown.

      Assuming that penicillin is a product of nature, certainly new methods of manufacturing penicillin are patentable. However, an old method of manufacturing a product cannot be re-patented just because it is applied to a previously unknown composition found in nature.

      See the distinction?

      1. 14.1.1

        Read the claim Ned. Its get mold that makes penicillin, feed mold that makes penicillin….That occurs in nature.

        Myriad, and all the other “laws of nature”, “products of nature” cases were wrongly decided.

        That’s why I addressed the Supremes.

  3. 13

    While I am not saying that Les is absolutely right in his view of “discovery,” it would be helpful for any and all those who do not want to believe that his view is indeed not correct to at least try to provide some meaning to the words of Congress in 35 USC 100(a).

    What does the fact that Congress recognized a distinction between what we call inventors and what we call discoverers means when Congress apparently opened up the possibility for patents for both of these different things.

    I invite – without snark – those who would dismiss discoverers to provide some (any) reasoning to this definitional and foundational aspect of patent law.

    Anyone up to that task…?

    1. 13.1

      “anon” I invite – without snark – those who would dismiss discoverers to provide some (any) reasoning to this definitional and foundational aspect of patent law.

      I look forward to hearing an answer from someone who is “dismissing discoverers”.

      As to why one isn’t permitted to obtain a patent claim to every non-obvious “discovery” that one makes during the course of one’s life, I think the question answers itself. And of course we all know that patents can be used to protect all kinds of “discoveries” if certain conditions are met, e.g., if the claim describes an advance over the prior art that is eligible for patent protection.

      1. 13.1.1

        If I brush aside the ad hominem short script and attempted goalpost moving and conflation that is the typical Malcolm post I see that Malcolm has not addressed the issue whatsoever.

        can you try again or at least please stfu and let someone address the simple and direct point of 35 USC 100(a).

        1. 13.1.1.1

          “can you try again or at least please stfu and let someone address the simple and direct point of 35 USC 100(a).”

          You’ve been inviting people to address this for years. Nobody wants to take your bait. And also your triple negative in the asking of the question is bound to leave people scratching their heads.

          link to i1.kym-cdn.com

          1. 13.1.1.1.1

            6 – it is a very straight forward item.

            Note that Malcolm chooses (porly) to not even bother to attempt the very simple item.

            I note too that YOU also do not bother to attempt, instead wanting to discuss me.

            P A Y
            A T T E N T I O N

            Try again to address the topic.
            Not me ( yes, I realize that you and Malcolm may find that difficult – but T R Y)

    2. 13.2

      “While I am not saying that Les is absolutely right in his view of “discovery,” it would be helpful for any and all those who do not want to believe that his view is indeed not correct to at least try to provide some meaning to the words of Congress in 35 USC 100(a).”

      Tttttttriiiiiple negative!

      1. 13.2.1

        You really having that hard of a time following along, 6?

        Way too funny.

        In that case, then try either post 10.1 or post 8.3.2.2.1.

    3. 13.3

      The thing is they could have crafted claims that were patentable, but they would have been more detailed and more narrow as they would have had to get into the specific choices they made in the identification process.

      The broadest claims in question simply claimed well-known techniques to look for material that was known to exist in the mother’s bloodstream.

      1. 13.3.1

        WOWthat was edited…?

        Let’s try again:

        Thank you for your (left standing) response. Those not left standing, well, I hope you get the picture.

        Here, though, I must admonish you as you TOO have failed to actually address the particular point under consideration, and quite in fact repeat the [___] errors of conflating 103 and 101.

        In one of your other responses today, all you do is offer the opinion – with NO explanation – as that 101 could be used for what is essentially (still) a 103 rejection.

        I invite you to try again, and this time try to stay on point.

        [that point being 35 USC 100(a) and the clear direction that Congress does recognize a difference between inventions (inventors) and discoveries (discoverers) and that BOTH are included in the proper domain of patents]

    4. 13.4

      anon, if patents are also limited to new compositions, how can the discovery of an old composition be patentable?

      The discovery then must be of a new way of applying the old composition to a new use.

      1. 13.4.1

        Thank you Ned, as you have come closest (while not quite making it) to staying on point.

        Please try again and address the actual point asked instead of asking a different question.

        (it’s not that your question is a “bad” question, it is just that your question does not in fact answer the point here – I am looking for a straight up H O N E S T answer to this direct point)

        So far, no one has been able to step up and deliver. The invitation still stands.

        1. 13.4.1.1

          All I am saying anon is that the term discovery does not exist the statute in isolation. In order to determine what discoveries are patentable subject matter one has to also determine whether the subject matter is a new or improved, machine, manufacture, process or composition. Among these, one cannot simply discover a new machine, manufacture or process. Therefore that leaves compositions. But the statute requires a compositions either be new or improved. Thus one cannot discover an old composition. Therefore with respect to compositions, the composition itself either must be new or improved or the discovery must be with respect to a new use.

          1. 13.4.1.1.1

            As I said – your question was not a bad question – it just does not address the immediate point.

            Try again.

          2. 13.4.1.1.2

            1. New means newly publicly known (see 35 USC 102).
            2. One can discover a new process (e.g., the krebs cycle, photosynthesis).
            3. As you note, one can also discover a new composition of matter (e.g., penicillin).

            4. Discovery of such things is clearly the sort of think the drafters would have wanted to promote.

            1. 13.4.1.1.2.1

              Les, 1. New means newly publicly known (see 35 USC 102).

              Patent Act 1790: they “have invented or discovered any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used”

              Patent Act 1793: “they have invented any new and useful art, machine, manufacture, or composition of matter, or any new and useful improvement on any art, machine, manufacture, or composition of matter, not known or used before the application,”

              “New” was added in 1793 as was “composition.” “not known or used” was retained.

              “New” does not mean “not known or used.” It has nothing to do with prior art. It has the to do with compositions and that they have to be new even though not previously known or used.

              1. 13.4.1.1.2.1.1

                ““New” does not mean “not known or used.” ”

                Yes it does Ned. I respectfully submitted that your quotes from 1790 and 1793 only go to prove it.

                I’m not sure why you quoted them. It may be that you think new, under my definition, would be redundant with “not known or used before ” in the version of 1793. My response to that position is that under your definition, it would be redundant with “invents.”

                New means not previously known (see 102). There is nothing to discover (uncover) but laws of nature and natural phenomena.

                1. Les, there is no way to reconcile your version with events (1790-> 1793).

                  One can invent something already known because he himself may not know it. However one cannot get a patent on that which is known regardless that the inventor did not know if it personally.

                  In contrast, one cannot patent a composition that is not absolutely new even if it was not previously known or previously used by anybody. It is amazing that it took until recent times for the Supreme Court to actually hold that a composition found in nature was not “new” under 101.

                2. Also, you still have not addressed 35 USC 100(b).

                  Please do so.

                  In a direct and inte11ectually honest manner.

                  Thanks.

                3. As I pointed out previously anon, and probably many times I pointed out previously anon, one might discover the “New World” but that does not mean the New World is “new.”

                4. “One can invent something already known because he himself may not know it. However one cannot get a patent on that which is known regardless that the inventor did not know if it personally.”

                  No. One can’t. One might think one invented something. However, if it already existed, one did not invent it. If Myron Hornbuckle made a contraption for separating seeds from cotton two years after Eli without knowing about Eli, we would not call Myron the, or even an, inventor of the cotton gin. That title goes to Eli.

                5. Ned –

                  How do we know that Crestor and Lipitor have never been created in nature? How dare we issue patents for them just because no one has yet FOUND them in nature.

                  The answer my friend, is that “new” means not previously known in the society issuing the patent!

                6. Ned,

                  “create”…

                  You are being circular again.

                  Also, you still have not addressed 35 USC 100(a).

                  Please do so.

                  In a direct and inte11ectually honest manner.

                  Thanks.

  4. 12

    At 1, way below, MM points out that the claim at issue fails to recite the solution to the problem. That reminds me of the EPO line, that what is patentable is the solution a technical problem. Merely reciting the problem to be solved ain’t enough.

    Which tool does the EPO use, to enforce this line? Prior to issue, Art 84 EPC (clarity, what you call definiteness). But as Art 84 is not a ground of revocation, it falls to Art 54 and 56, novelty and obviousness, to do the job.

    As to “discovery “, back in the 18th century this meant something like the discovery process in litigation, something uncovered (or made available to the public). The patent bargain, rights in return for disclosure.

    As to the limits of eligibility, I like patents on technology but abhor patenting science.

    1. 12.2

      HEY NED, DID YOU SEE THIS:

      “As to “discovery “, back in the 18th century this meant something like the discovery process in litigation, something uncovered (or made available to the public). The patent bargain, rights in return for disclosure.”

      1. 12.2.1

        No it did not, Les. It meant something like “Columbus discovered the new world.”

        New here meant that what we now regard as the America’s were not then known and that their discovery made them known.

        But “new” in the 101 context means “not preexisting as a matter of fact.”

        The problem is that we have one word that means different things depending on context. That is not unusual in the English language.

        1. 12.2.1.1

          ..and yet Ned, in the brand new spanking AIA, “new” is deliberately set forth as “new to you” with the case of Metallizing being expunged per the words of Congress (see The Soliloquy)

          1. 12.2.1.1.1

            Anon, I did not see any changes to 101 in the AIA on this topic.

            Whether something is prior art or not goes to the historical analysis of “known and used” that first appeared in the statute in 1790. New does not mean or have anything to do with whether something was known or used at the time of invention. “New,” however is an independent requirement that exists regardless of whether something was known or used.

            1. 12.2.1.1.1.1

              Your “version” remains Wack Ned. How often must I remind you that before 1952, the item you want to parse out was part of a SINGLE paragraph?

              You want to look at a ‘verbatim’ words, and IG NORE all of the other context that happened in the Act of 1952.

              You just cannot do that – not in ANY inte11ectually honest sense at least.

        2. 12.2.1.2

          “But “new” in the 101 context means “not preexisting as a matter of fact.” ”

          Why? Because you say so, or because you want it to be so?

          For the meaning of new in the patent sense, see 102.

          1. 12.2.1.2.1

            Les,

            It is clear that Ned employs the circular logic of “want.” He is only too wiling to ig nore the important context involved in order to arrive at the ends of his mantra.

  5. 11

    Did these judges actually read the Mayo and related decisions?

    Did they (and Prof. Couch) actually read the entire claim as required?

    Method claim 1 is limited to “performed on a maternal serum or plasma sample from a pregnant female”.

    Yes, PCR and immunoassays are known but as clearly stated in specification:

    “It has now been discovered that foetal DNA is detectable in maternal serum or plasma samples. This is a surprising and unexpected finding; maternal plasma is the very material that is routinely discarded by investigators studying non-invasive prenatal diagnosis using foetal cells in maternal blood.”

    Yes, it was known to PCR/Immunoassay blood samples, but the claim is limited to
    “maternal serum or plasma sample from a pregnant female” (contrary to the broader suggestion in paragraph 3 above that refers to “mother’s blood”).

    So, claim 1 is not directed to a natural law/phenom or abstract idea since requires concrete steps never performed using maternal serum or plasma.

    Even if arguable “natural/abstract”, the specification clearly sets forth why the additional limitations (including the type of sample used) is inventive.

    The Fed Cir should have granted a en banc hearing, but likely a waste based on their collective comments.

    Next step: Supreme Court cert request.

    We definitely need to Supreme Court to revisit and clarify.

    1. 11.1

      splinter: claim 1 is not directed to a natural law/phenom or abstract idea since requires concrete steps never performed using maternal serum or plasma.

      That’s not how the subject matter eligibility analysis works. Just because you discover a new natural phenomenon doesn’t mean that you can prevent other people from looking at the same phenomenon using generically recited conventional techniques that were created especially for that purpose (i.e., looking at that class of phenomena). If that were the case, I could discover a new naturally occuring virus and then remove it from the public domain by claiming the use of conventional methods of looking at viruses to (wait for it) look at this new virus. According to your “analysis”, such a claim is “not directed to a natural phenomenon” because nobody had previously used those conventional techniques on “compositions comprising the new virus.” Most people will agree that your analysis is stillborn. It would punch a gaping loophole in 101, just as Prometheus’ claiming strategery would have done.

      Did these judges actually read the Mayo and related decisions?

      Yes, they did.

      the specification clearly sets forth why the additional limitations (including the type of sample used) is inventive.

      No doubt you are aware the Ariosa had originally tried to obtain and enforce even broader claims than the claims asserted here. Remember: an explanation in the specification as to why the alleged inventors believe that something is “inventive” is not at all probative of the issue as to whether that something is, in fact, inventive. For example, the specification could explain why the inventors believed that they invented the world and everything in it. So what?

      Furthermore, it’s not disputed that PCR was performed on both maternal blood and serum prior to the critical date. And guess what? It worked. Of course it worked. The only “new” thing here is the name given to some of the DNA molecules floating around in that blood. Fetal DNA isn’t some sort of completely different chemical composition other human DNA. It’s still just DNA. PCR doesn’t care what we call it.

      1. 11.1.1

        Your unknown virus was no more in the public domain prior to your discovery of it that was the cotton gin prior to the invention of it.

        1. 11.1.1.1

          Les, hand over the ca keys.

          Whether or not he virus is known is quite separate from whether it exists “in the public domain.”

          Think “inherency.”

        2. 11.1.1.2

          Your unknown virus was no more in the public domain prior to your discovery of it

          Likewise with that very particular piece of gold lying in the very particular piece of ground. But that’s not the point.

          The point is that “using a shovel” to move dirt around is most definitely in the public domain. That doesn’t change just because you recite some “new” coordinates where nobody shoveled before (or described “in a printed publication” as a place to dig). Presumably you and everyone else can see the problems that would inevitably arise if your rule is applied. If you’re having difficulty, try stepping out of your patent lover’s shoes for a second and look at the situation from the perspective of the zillions of folks who’ve been freely using shovels to dig up stuff, everywhere they like, for many years.

          1. 11.1.1.2.2

            What?

            Who is stopping people from shoveling “generally”?

            Using this new analogy of yours, a patent is like staking a claim to the hole where the I found the gold and the area around it, not shoveling generally, just shoveling here in the area marked X.

            link to youtube.com

      2. 11.1.2

        ” just because you discover a new natural phenomenon” ?

        The claimed method is not a natural phenomenon. It’s a novel and non-obviousness method that involves using previously known processes (PCR and immunassays) on an extract from natural blood.

        No one has apparently performed those steps on a mother’s blood plasma (which was always discarded in past).

        The result is a new technique for determining pre-natal defects, etc.

        I cannot believe the courts of finding this invention not eligible for patentability regardless of how new, non-obvious and useful the test is.

        These decisions are horrible.

        1. 11.1.2.1

          splinter: The claimed method is not a natural phenomenon.

          Nobody is suggesting otherwise. If you’re going to simply beat on a strawman and ignore the issues and the actual analysis being applied then there’s no point in discussing the case or the issue with you. Rant away!

          I cannot believe the courts of finding this invention not eligible for patentability regardless of how new, non-obvious and useful the test is.

          You better learn to believe it, friend, because it’s the law and it’s not going to change. To be more specific: subject matter eligiblity is never waived merely because the ineligible subject matter is non-obvious and valuable. It’s a feature, not a bug, and the Supreme Court is well aware of it.

          Justice Breyer put the spotlight on the issue in the oral arguments in Mayo with a great hypothetical “discovery”. Specifically he postulated an incredibly useful and non-obvious discovery whereby fingernail length was correlated with some terrible disease. Could you claim “Determining likelihood of terrible disease by looking at fingernail length and correlating said length with said disease”? The answer, of course, is NOPE. That answer is not a judgment on the awesomeness of the discovery. It’s a judgment on what sort of claims belong in a patent system if we expect the patent system to function.

          1. 11.1.2.1.1

            ….and (following the Breyer line) there is some rare dread disease of the potato (or wheat or rice) plant which is treatable (if I spot it early enough) by application of a particular expensive and known fungicide X, and if I discover a correlation between leaf shape (rather than finger nail length) and the disease, can I have a patent on a method of spraying potatoes with X, characterized by the step of correlating dosage X with determined leaf shape? Is the answer “Of course not” or does it depend on exactly what I claim?

            1. 11.1.2.1.1.1

              Is the answer “Of course not” or does it depend on exactly what I claim?

              I think if this fungicide is already known to be useful for treating the disease in question, you’re in a tough spot (analogous to the Breyer scenario). Your best bet would be to recite an innovative method of determining the leaf shape of the plants.

              1. 11.1.2.1.1.1.1

                Thanks MM. Tough? Sure. That was the aim.

                I had in mind that my leaf shape test enables earlier diagnosis than hitherto, thereby raising both yield and standards of plant husbandry. It seems to me then, that it ought to be patentable.

                1. So let me make sure that I understand your position, MaxDrei…

                  You believe that the mental recognition alone of a fact of nature ought to be patentable?

                  It appears that you want “enablement” and not actual timed improvement to be enough.

                  Your position appears to not even rise to the level of Funk Brothers, as that case had to use a mixture of separate natural facts.

                  If I am off, please let me know.

                  If I am not off, perhaps this is your contribution to the question posed at post 13.

                  But please be sure to note that I am NOT passing judgment on your view here – I am merely seeking clarification.

          2. 11.1.2.1.2

            Nobody is suggesting otherwise.

            You do realize how very little credibility there is in that statement, right?

          3. 11.1.2.1.3

            Malcolm, I think the issue is broader than just that a law of nature is involved. I think that any process claim that only produces new information as an output is not the subject matter of the patent system.

              1. 11.1.2.1.3.1.1

                Surely you jest – because something must be encrypted and to be useful that something must be a single.

                1. Thanks, anon.

                  Dragon may have meant single. But I may have meant something else that sounds similar.

                2. The question still remains Ned, now doubled down by your odd answer (you may have meant something else that sounds similar…? May?)

                  Maybe you want to follow through and actually provide that answer and remove the “may”….?

                3. anon –

                  single sounds like jingle and if you hum the tunes Ned usually sings and think about the rest of Ned’s post; overlay that with the sort of errors Dragon can sometimes make, in its efforts to be lingual, your brain will likely tingle when you replace single with “patent eligible” or horror of horrors, “patentable”.

                  Pardon me, I should really mingle.

      3. 11.1.3

        Malcolm,

        Your repeated attempts at analogies of “looking at it” fall to being mere fallacies because you do not even attempt to note that 101 includes the requirement of Utility.

        Maybe you should build better analogies….

          1. 11.1.3.1.1

            “Looking at” in and of itself fails to have the utility as would be understood by anyone being inte11ectually honest in discussing patent law.

            Then again, it is known that you lack such.

  6. 10

    The first-to-file approach for deciding inventorship has been widely criticized as missing the main point — actual inventorship. If laws of nature were patent eligible without actual invention, then a race to the patent office would be the only test whenever a law of nature is discovered.

  7. 9

    There is a reason why patents have limited terms. They have the potential for inhibiting or prohibiting technological development through the exclusivity granted to patentees. This is offset by the incentive they provide for actual invention, not commercial expediency.

    In Mayo, the Supreme Court correctly decided mere application of conventional technology to newly discovered laws of nature are not eligible for patents. Whether “something more” or “inventive concept” is the appropriate test is debatable, or needs refinement, but in this case the patent fails to disclose and claim anything beyond application of conventional methods for a newly discovered law of nature. It would allow the patentee to restrain competition and prohibit diagnostic development by others without contributing its own invention.

    The Federal Circuit correctly denied en banc review, and a petition for cert is a non-starter.

    1. 9.1

      That may have been a “legitimate” legal principle prior to 1952, Jai Rho.

      But the power of the judicial branch – loaned to it by the legislative branch – to set the meaning of “invention” by common law rule making was revoked.

      Separation of powers is not just between the executive and the judicial.
      Separation of powers is not just between the executive and the legislative.
      Separation of powers is not just between the judicial and the legisaltive.

      Not ONE single branch of the government is above the law and can set aside the constitution at its whim.

    2. 9.2

      Whether “something more” or “inventive concept” is the appropriate test is debatable, or needs refinement, but in this case the patent fails to disclose and claim anything beyond application of conventional methods for a newly discovered law of nature.

      Yup.

      Maybe “use PCR” has the same effect on people’s brains that “computer network” has. People just shut down their analytical reasoning and pretend they were born yesterday because OMIGOD PCR ACTUALLY WORKS! Plus you tug at some heartstrings with the fetus/m 0ther aspect. Kind of a perfect storm.

      Think about it this way: before the critical date for Ariosa’s application (1997, according to the PTO) it was known that fetal cells were getting into maternal serum. Where there’s fetal cells floating around, there’s bound to be some small amounts of fetal DNA floating around. It was also known that there was nothing special about maternal serum that prevented PCR reactions being performed on maternal serum.

      In the years preceding that critical date, scientists were already using PCR to identify and characterized uncultured bacteria growing in minute amounts of dirt. Heck, people were not only contemplating but reporting the successful use of PCR to isolate DNA from 30 million year old speciments of insects trapped in amber. That’s the theoretical power of the method, as generically understood by the scientific community in 1997. The devil was in the details of the methods used to clean up the sample, the specific primer sequences that you chose, the PCR reaction conditions and — most importantly — the controls.

      1. 9.2.2

        It was also known that there was nothing special about maternal serum that prevented PCR reactions being performed on maternal serum.

        That’s your argument? IT could have been done?

        That’s not even a study plan type of argument.

        1. 9.2.2.1

          “It was also known that there was nothing special about maternal serum that prevented PCR reactions being performed on maternal serum.”

          That’s your argument?

          No, it’s a basic fact that’s part of my argument about the conventionality of the detection technology recited in the claim.

          IT could have been done?

          Right. And even more importantly, people understood at the time that you could perform PCR on human serum because (surprise!) people had performed PCR on human serum before. There was no belief among skilled artisans that human serum (maternal or otherwise) was filled with mysterious (or known) anti-PCR chemicals. Likewise there was no belief that fetal DNA was somehow “special” and impossible to detect with PCR, either alone in a tube or mixed up with maternal DNA.

          1. 9.2.2.1.1

            Your reply is not enough to distinguish the point put to you.

            What could be done with ANY t00l is simply not enough to eliminate what IS done and had not been done before.

            The logic you use here is the same logic that I make fun of with my Big Box of electrons, protons and neutrons.

            It is amusing that you seem to not want to see that, and yet, you continue to merely repeat the same script.

            You need to open your eyes.
            You need a better script.

        2. 9.2.2.2

          Applying well-known techniques to solve a well-known problem is not an invention. These claims would have been rejected under 103 anyway. However, I believe that applying well-known techniques to detect natural phenomena is arguably 101-rejectable.

  8. 8

    Hey, the federal circuit actually applied the precedent and stated reasons why it might not be a good idea! Good job FC, that is how you law.

    I’m somewhat sympathetic to the patentees in this case, but I simply see no manner in which you could craft a rule that would allow this case but deny “I shined my flashlight on something new so let me re-patent the using the flashlight and patent interactions with the new thing” type claims.

    Of course giving people money is an incentive. Of course (any real) applications have utility. It does not follow that we give money for every non-obvious piece of information that is useful. News reporting is useful. Political treatises are useful. Mathematical proofs are useful. You don’t see people keeping mathematical proofs to themselves purely because they don’t get an exclusionary right for disclosing them. It’s not a terrible thing to tell these people that they will have to live with the notoriety of having helped unborn children and made a difficult procedure easier to perform for themselves (even if other people get to “freeload” on that ease too).

    If there was some sort of “one-shot” rule which would give them the right to employ one of a plurality of methods (in license with the inventor of that test, of course) while inherently dedicating all the other methods to the public I would be in favor of it, but that would require a pretty extreme change to the law. What certainly can’t happen is the scope here, where they discover a fact and then prevent all tests that could occur. It’s extremely obvious that you can’t get into a situation where you’re allowing someone to achieve a monopoly rather than an exclusionary right.

    I’m not sympathetic to the patentee insofar as they do what most applicants try and do – they try and use patent law, which is designed to protect someone from copying your machine, in a manner where not only can’t they copy your machine but they can’t compete with you because you claim has subsumed all options.

    1. 8.1

      Random,

      You really need to try to keep your “logic” appropriate – and not attempt to mix the Useful Arts and the Non-Useful Arts.

      NOTHING you said above even begins to make sense since you don’t observe that foundational understanding.

      1. 8.1.1

        You really need to … not attempt to mix the Useful Arts and the Non-Useful Arts.

        I don’t see where RG is attempting to do that. Perhaps you can explain what you’re talking about? Try to remember that we’re not talking about these issues in a vacuum. If applicants are mixing up these “useful arts” and “non-useful arts” in claims, please recognize that we’re necessarily going to talk about both those things. Your comfort level with those discussions is less than irrelevant. Perhaps you can begin by defining your terms, thereby minimizing the possibility of your humptydumptying the thread.

        1. 8.1.1.2

          Let’s try this:

          I don’t see

          Of course not [_____]. There are none so blind as those that will not see.

          As to “comfort level”…, well that’s a pretty strawman, since no one, least wise me, said anything about comfort level.

          You just don’t get to conflate terms and then say that you need to conflate things. Bad logic doubled down atop bad practice.

          Lastly, you engage (yet again) in your favorite accuse others meme by wanting me to define some unspecified terms while you introduce a term of “humptydumpting” whatever that means.

    2. 8.3

      The second paragraph highlights the most disappointing aspect of the judges’ writings: they do seem to understand the systemic problems presented by Prometheus-style (“determine and infer”) claims but, unless I missed it, they don’t do a great job of articulating the similar problems presented by “detect my discovery using conventional means” type claims.

      1. 8.3.1

        Apologies — not clear what I was referring to (quoting RG caused the comment to get stuck in the filter for some reason). The “second paragraph” I referred to is the paragraph in RG’s comment stating “I simply see no manner in which you could craft a rule that would allow this case but deny ‘I shined my flashlight on something new so let me re-patent the using the flashlight and patent interactions with the new thing’ type claims.

      2. 8.3.2

        Adding: Discovering new facts about the world is what scientists do. The vast majority of those facts are collected using public domain t0 0ls. Endless piles of useful non-obvious scientific data are generated in this manner and published every day without any patent incentive whatsoever, and that’s been happening for many many years. If, as a country (the greatest country in the history of the universe, I’m told), we can afford to obliterate entire nations and rebuild them because “freedom”, I’m pretty sure we can afford to pay scientists to generate publically usable knowledge for public benefit. It’s worked before.

        Promoting the patenting of “detect this fact” claims would only worsen the State Street Bank fiasco that the system is just beginning to recover from. The dial doesn’t need to be set at 11 again, ever.

        1. 8.3.2.1

          I’m pretty sure we can afford to pay scientists to generate publically usable knowledge for public benefit. It’s worked before.

          O Rly?

          Care to share this period of Utopia (and why we are no longer in that Utopia, and what has been the relative advancements and rate of advancements?

          Serious questions (sadly with no hope of actual answers).

          1. 8.3.2.1.1

            “I’m pretty sure we can afford to pay scientists to generate publically usable knowledge for public benefit. It’s worked before.”

            O Rly?

            Yes, really. What planet are you from?

            1. 8.3.2.1.1.1

              Maybe some specifics Malcolm….

              (You will pardon me if I don’t go on just your “feelings”)

                1. Sorry LH, but no. That just does not reach the detailed breadth of the claim that Malcolm put forth.

        2. 8.3.2.2

          Actually, MM, I think there really is a constitutional problem in granting patents to people who discover existing things because they are not inventors.

          1. 8.3.2.2.1

            Without taking a position on your comment, Ned, I have a serious question for you: what does 35 USC 100(a) mean to you?

        3. 8.3.2.3

          “I’m pretty sure we can afford to pay scientists to generate publicly-usable knowledge for public benefit. It’s worked before.”

          Sold to me. You will find reality debates in your face lots more often.
          Heck, the West could try Civilization, as Gandhi suggested.
          It worked for the Greeks in 300 B.C.E.

  9. 7

    As the AIPLA has just noted:
    “Judge Dyk noted that Mayo claims were directed to a law of nature, and that the claimed steps applying that law of nature were “well known” and thus does not present an “inventive step.” He considered Mayo’s conclusion that an inventive concept cannot come from discovering something new in nature, and said this: “In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself.”
    He disclaimed any intent to say a newly discovered law of nature should be patent eligible in its entirety, but opened the door to something short of that:
    “[I]f the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice, I think that the novelty of the discovery should be enough to supply the necessary inventive concept.”
    —–
    Even in this view of J. Dyk, is not the IF “the breadth of the claim is sufficiently limited to a specific application …” qualification the very problem with the broadest [premptive?] claims of this patent?
    [And is the “and reduced to practice” requirement suggesting the usual 112 requirement for enabling disclosures for broad generic claims encompassing unlimited numbers of different specific applications?]

    1. 7.1

      Dyk: “[I]f the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice, I think that the novelty of the discovery should be enough to supply the necessary inventive concept.”

      PM comments: Even in this view of J. Dyk, is not the IF “the breadth of the claim is sufficiently limited to a specific application …” qualification the very problem with the broadest [premptive?] claims of this patent?

      Indeed. I had the same reaction immediately upon reading that passage. The “sufficiently limited” business is just a restatement of Mayo’s “something more.”

      The fact of the matter is that however you cut the mustard you logically end up the same place. You can’t turn an obvious process into a patentable process merely by reciting some otherwise ineligible subject matter (no matter how novel or surprising or useful that ineligible subject matter may be). And you can’t turn that otherwise ineligible subject matter into a patentable process merely by reciting some obvious process.

      Yes, this means that some hugely important discoveries about the natural world will be impossible to protect with a patent. That’s a feature, not a bug.

      1. 7.1.1

        Your “logic” is skewed as you are doing that very same confront 103 and 101 (obvious and eligible if) thing that you oh so recently claimed that you were not doing.

        1. 7.1.1.2

          conflate 103 and 101

          This accusation has lost whatever meaning it once might have had thanks to rampant overuse by people who are unwilling to follow (or incapable of following) some elementary legal reasoning.

          Evaluating the eligibility of a patent claim with an understanding of the claim’s relationship to the prior art is not “conflation.” It’s the law.

          1. 7.1.1.2.1

            Nonsense Malcolm.

            It is you that “F A I L S to follow some elementary legal reasoning. You do not then get to claim that because people F A I L (like you), that you get a pass.

              1. 7.1.1.2.1.1.1

                Caught in the filter…

                Basically Malcolm all we see here is “more” of the same worthless C R P type @ccuse 0thers of what you do.

                Nine years and running, and well on your way to an even decade.

      2. 7.1.2

        Spot on!

        These are patents that should never have been issued. The method in question was obvious even way back in 1997.

        And what greatly amused me was the appalling quality of the submissions made by some of the “amici”. “Misleading and deceptive” would be an apt description of their efforts or was it that they were simply clueless about the technology central to the claims (PCR) and its application in the method?

        1. 7.1.2.1

          Rubicon,

          The means to that end (“should never have been issued“) are CRITICAL.

          Do you understand why?

    2. 7.2

      Who else can place the time in history that Congress decided to eliminate the judicial branch’s common law authority centered around this “inventive gist”…?

      Hint: EVERY patent attorney should be able to do so.

      1. 7.2.1

        this “inventive gist”…?

        Creating an obvious strawman (“inventive gist”) and attacking is rarely a successful strategy. That’s especially true at this late date.

        Congress never decided that natural phenomena or abstractions or laws of nature were eligible for patenting. They also never decided that logic was eligible for patenting, or information itself.

        It’s certainly free to make that decision now, if it wishes. Pretty sure we’ll bomb a few hundred more countries before that ever happens.

        1. 7.2.1.1

          No strawman at all Malcolm.

          Try to understand the actual history involved in the paragraph that became both 101 and 103 in 1952.

          It is rather important – and very much on point.

          1. 7.2.1.1.1

            Try to understand the actual history

            I understand it very well but thanks for your concern. Do you have anything else to add? Perhaps you’d like describe the relevant history in detail, with emphasis on the Congressional record as it relates expressly to the protection of correlations and natural phenomenon with patents.

            That’d be refreshing.

            1. 7.2.1.1.1.1

              Clearly, you show no understanding of history (and why Congress was prompted to react against one of the most anti-patent Supreme Court eras that produced the phrase “the only valid patent is one that has not yet appeared before us.

              As for describing in relevant detail, asked and answered – as I have not only shared legislative history, the direct words of Congress, the background as provided at the Cornell Law website, but also the pertinent writings of both Federico and Rich.

              I have to laugh at your feeble attempt to “want more,” especially seeing the absolute lack of anything substantive that you have “provided.”

              1. 7.2.1.1.1.1.1

                “anon” the most anti-patent Supreme Court eras that produced the phrase “the only valid patent is one that has not yet appeared before us.

                Oh, how awful it must have been for your ancestral patent lovers.

                1. Your “care” is noted.

                  As is the lack of any substantive reply to the point at hand.

                  Maybe try again…?
                  This time say something meaningful…?

  10. 6

    A correct legal decision that properly applied the SCt precedent. The difficult policy issue behind this difficult legal issue seems to be: should we encourage discovery of valuable things in nature by allowing patents to be awarded based on the discovery itself? In particular, when discovery of those things is difficult and involves creativity and ingenuity.

    Here is a possible solution. If someone discovers something in nature, give them the first and only shot to claim an application or use of the discovery where the patentability hinges on the new discovery and not the method/composition/etc. that make the discovery useful. Alice already prevents overbroad claiming, and others can’t make claims that rely on the newness of the discovery. In other words, keep the rule Ariosa/Mayo, but with an exception for the first discoverer, so the discovery in nature is not “locked up”.

    Another possible solution would borrow from copyright law. How was the thing in nature discovered? Was it labor and sweat of the brow, a rote process and discovery was inevitable. Or, was the discovery itself a clever and ingenuous one. Look at the circumstances of the discovery.

    1. 6.1

      Doesn’t 35 USC 101 state the following: “Whoever invents or DISCOVERS any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Why does discovery have to be a clever and ingenious one, instead of one that is merely stumbled upon? And how is a “discovery” ever clever and ingenious?

      I know of a person who discovered that one way of doing something did not work (because the “thing” failed). They then discovered a slightly different way of making the same thing, and this different way worked. If this wasn’t clever or ingenious, what about 35 USC 101 says that this discovery is not patentable?

      Where is Scalia with his plain reading of 35 USC 101 when we need him? ;-)

      1. 6.1.1

        Understood, but do the four enumerated classes cover a fact that was always present in nature? The only one that seems to make sense; “composition”, but that connotes “composing”, as in, making something. The statute does say “discover”, but hard to ignore the words it operates on.

        1. 6.1.1.1

          Every thing is composed of electrons, protons and neutrons.

          Outside of such things, albeit currently outside of the (wrongly) decided >I>In re Nuitjen, manufactures cover “things” outside of the “things” of compositions per the electrons, protons, and neutrons model.

          There is a certain (purposeful?) lack of appreciation of the fact that 101 was meant to be a wide open welcoming gate.

          To what end is the closed-mindedness so heavily embraced?

          1. 6.1.1.1.1

            You’re preaching to the choir, brotha. I just agree with the idea that finding a new frog or plant in the amazon rain forest isn’t the kind of “discovery” the patent laws are intended to encourage.

            I bring up copyright partly because my recollection is that the seminal copyright decisions do a good job of making hard choices based on the underlying copyright policies. The court’s comfort with relying on policy to make difficult decisions seems to be lacking in patent decisions, maybe because policy factors aren’t built into the patent statutes, unlike the copyright statutes. In any case, if the CAFC were doing a better job of shaping patent law at the lower appellate level, then we wouldn’t have the borderline-incompetent Supreme Court making a mess of so many issues.

            There have always been limits to what subject matter is patentable. To me, the subject matter limits should always come back to: is X the kind of “new thing” we want, is Y the kind of human activity we want to encourage to get things like X, and is a grant of an exclusive right worth getting X?

            The 101 body of law has gotten bogged down in red herrings. The silliness of arguing about whether something is baryonic matter or energy doesn’t help answer those questions.

            So coming back to your point about the expansive intent of section 101, more reliance on a simple policy/incentive analysis would be consistent with 101’s broad language. I mean, why shouldn’t abstract algorithmic inventions be patentable, be they algorithms for games, or for organizing human activity, or for mathematics, assuming such patents meet the policy objectives? Who doesn’t want to board an aircraft 5x faster, or have their computer accomplish things faster 100x, or play clever and interesting games?

            Look at the RSA asymmetric encryption invention. It’s pure math, but exceptionally clever and useful and not a building block of mathematics. They got their patents, but today, I’m not so sure. And that type of innovation should be claimable as pure math. It should always come back to what human beings are doing and how they are doing it and the effects of a patent grant.

            1. 6.1.1.1.1.1

              You assume too much with “ In any case, if the CAFC were doing a better job of shaping patent law at the lower appellate level, then we wouldn’t have the borderline-incompetent Supreme Court making a mess of so many issues.

              It should be abundantly clear that the Supreme Court has an addiction for sticking its finger into the 101 nose of wax – regardless of what the CAFC does.

              That’s why the only real long term answer is in jurisdiction stripping – which, since patent appeals are not a matter of original jurisdiction for the Supreme Court, the Congress has every legitimate constitutional power to enact.

              Congress rose up and rebuffed the Supreme Court way back in 1952.

              It’s time again – and this time to do so in a way that cannot be mashed again.

              1. 6.1.1.1.1.1.1

                Congress rose up and rebuffed the Supreme Court way back in 1952.

                It’s time again – and this time to do so in a way that cannot be mashed again.

                Or Congress can keep rebuffing you and your cohorts because you are the world’s most deserving targets.

                1. How has Congress “rebuffed” me and my “cohorts”….?

                  What does that even mean?

                  Use those short declarative sentences you are always on about.

                2. How has Congress “rebuffed” me and my “cohorts”….?

                  Among other things it legislated the AIA to make it easier to get rid of the junky patents that you never seem to tire of defending.

                  Now go ahead and pretend that was exactly what you wanted.

                3. More dissembling from you Malcolm, as I defend no such claims.

                  You mistake my actual discussion of of law at the big picture level – and it is abundantly clear why you (purposefully) dissemble on that point.

            2. 6.1.1.1.1.3

              HoPB: [1] why shouldn’t abstract algorithmic inventions be patentable, be they algorithms for games, or for organizing human activity, or for mathematics

              [2] Who doesn’t want to board an aircraft 5x faster, or have their computer accomplish things faster 100x, or play clever and interesting games?

              Two completely different questions.

              As for your assumption (“assuming such patents meet the policy objectives”) you are losing that debate bigtime — and you’re going to continue to lose it — for a variety of excellent reasons. The number one reason is that the patent system we have now is completely unequipped to competently examine and evaluate “new” algorithms against the prior art. That’s why so many patents on computer-implemented logic get tanked in IPR. The PTO could never figure out how to examine them (again, for good reasons). And based on the incredibly feeble efforts of the folks who comment here (who claim they can distinguish between “good” logic patents and “bad” logic patents), they’re not going to get any help from the applicant side.

              1. 6.1.1.1.1.3.1

                Apologies for the runaway formatting. I only meant to bold “completely unequipped to competently examine and evaluate “new” algorithms against the prior art.”

              2. 6.1.1.1.1.3.2

                Two completely different questions.

                Why are they two completely different questions? Maybe you want to try to square your statement here and your past statements that “software is just math”…?

                Clearly, software is NOT just math. Is that what you are saying here? If so, why not say it directly?

                As to any sense of “the Office is not equipped to examine”… that is a canard and a fallacy (circa 1968) that should have ZERO bearing on the eligibility question. ALL new areas of innovation would be foreclosed from patent protection with that type of “logic.” You use the meme sometimes of people being “deep in a cave” and yet do not see that your own “logic” here places you far deeper into that cave than anyone you would deem to insult with that meme.

                Of course, this tendency of yours is your signature mark. Sadly, no one seems to care that you simply don’t care how duplicitous this is.

                1. no one seems to care that you simply don’t care

                  Correction: you care.

                  But nobody really cares what you think about anything.

                2. There you go again accusing me of what fits you.

                  I bet the irony escapes you.

                  The point there about my mentioning the “care” was the whining from the good Prof. and a select few others when it is beyond clear exactly who is the blight here. Nine years and running – well,well, well before I started posting here.

    2. 6.2

      “but with an exception for the first discoverer, so the discovery in nature is not “locked up”.”

      What is the harm in “locking up” the discovery for the life of a patent?

      No one knew about the discovered item before the discovery. Know one could use it for any application. Why shouldn’t the discoverer be allowed to control and get part of the benefit of her discovery for any and all subsequent applications of that discovery for 20 years or so in exchange for disclosing the discovery?

      1. 6.2.1

        To me, it’s a policy question. What are the types of activities that should be encouraged by the patent regime? Should we reward people who just take genomes from any organism, sequence them, claim chunks of that genome based on some arguable usefulness, and then let them exclude anyone else from doing … something … with the stuff that was there all along.

        I understand the concern behind Mayo. Why should we grant exclusive rights on new areas of discovery for things that really only require routine lab work, some automation, and little human ingenuity? On the other hand, some discoveries require rigorous application of the scientific method and ingenuity in doing so.

        How hard would it be to have a rule that encourages/rewards difficult discoveries for which there was no sign of inevitability? Let’s reward the people who are adding real value, not the craftless searchers. The issue in Ariosa should have been: was this discovery obvious or inevitable, or was it unlikely to have occurred without someone having the clever insight of the inventor?

        So Mayo has it’s purpose, but it’s too rigid of a law, which I think the CAFC is saying, in so many words. Some discoveries should be patentable.

        1. 6.2.1.1

          You do realize that policy is not for the Court, right?

          Expressly so in our Constitution (for patents).

    3. 6.3

      HOPBs

      I do not think that you are applying the copyright schema appropriately.

      Remember one of the cardinal differences:
      copyright: expression
      patent: utility

      And please remember that some things have BOTH of these aspects – they are not mutually exclusive.

      1. 6.3.1

        please remember that some things have BOTH of these aspects

        Indeed, virtually everything has both those aspects — depending on how you choose to define the terms. Therein lies the rub.

        1. 6.3.1.1

          No rub at all.

          Why do you “see” a rub?

          Different aspects protected – appropriately – by different IP laws.

          1. 6.3.1.1.1

            Why do you “see” a rub? Different aspects protected – appropriately – by different IP laws.

            At least one rub occurs when one of the “different IP laws” is used — intentionally or otherwise — to protect “aspects” that it wasn’t designed to protect. Surely you can think of examples on your own. If not, I’m happy to provide for the billionth time.

            1. 6.3.1.1.1.1

              You are merely assuming the conclusion you want to reach.

              Try to remember the basics, son:

              Patents: utility
              Copyright: expression

      2. 6.3.2

        I’m not suggesting duplication of a rule. But, there is a policy that limits what can be copyrighted. This will probably be a little bit inaccurate, but my recollection is that copyright can only lie in creative expression. The “sweat of the brow” rule says that you can’t copyright a work that lacks sufficient expression or creativity. Classically, that would be old telephone directories. Someone painstakingly collects a bunch of phone numbers and publishes them. No copyright allowed. So put the same concept to use in the area of discoveries of nature.

        Automation can lead to some really useful discoveries. There are optimization algorithms that can design pretty decent antennas, for instance. It is possible to perform expansive automated searches for biological phenomena and correlations, using many techniques for high throughput screening. Why should we award a patent to someone because they ran some machinery, which anyone could do?

        1. 6.3.2.1

          HOPBs,

          From above you mention “Or, was the discovery itself a clever and ingenuous one. and here you want to have some sort of “creativity” factor.

          I do hope you recognize the history fo your view and that Congress explicitly rejected this very type of thing. See the run-up to the Act of 1952 and the whole Flash of Genius thing.

          (and by the by, there is copyright in phonebooks – but it is a mere thin one of the creativity of choice of layout of the facts)

          1. 6.3.2.1.1

            Congress explicitly rejected this very type of thing. See the run-up to the Act of 1952 and the whole Flash of Genius thing.

            All that Congress rejected was a rule that required a showing of a Flash of Genius to obtain a patent.

            Non-clever “innovations” — whether they are dreamt up or “discovered” — are often easily tanked under 103 because of a lack of unexpected results.

            1. 6.3.2.1.1.1

              LOL – my point exactly Malcolm.

              Oh wait, you still don’t even realize that you are conflating 103 and 101, eh?

  11. 5

    I have to qualify that at the time the patent application was filed (March 4, 1997), there was no hypothesis “that fetal DNA might be floating around in the mother’s blood and that the fetal DNA could be selectively amplified by focusing on the paternally inherited portion of its DNA (rather than the maternally inherited)”.

    Both parts of the hypothesis were proven at least as early as 1993.

    Here is one paper: Isolating fetal cells from maternal blood. Advances in prenatal diagnosis through molecular technology.

    There is a sort of cottage industry for grad students and others in the life sciences. They research papers that would invalidate important pharma patents and then extort money from patent holders with the threat of going to the public (or to competitors) with the invalidating information.

    As online article databases improve, this type of extortion should occur less frequently because bogus claims should not be allowed because competent examiners should be able with ease to find prior art that anticipates or makes it obvious to try.

    Of course, the qualification of “competent” is extremely important.

    1. 5.1

      What does this 103 argument have to do with 35 USC 101? If they could’ve made a 103 argument, why didn’t they?

      1. 5.1.1

        Because 103 arguments are expensive and even post-KSR most examiners cannot be relied on to apply the obviousness standard properly (also they typically do not have easy access to the scientific journals needed for proper examination of “discovery” patents). In many ways current 101 jurisprudence exploded because its pleadable and its cheaper to appeal a 101 case to SCOTUS than it is to take a case to trial.

        1. 5.1.1.1

          Expensive…?

          You want an Ends regardless of the propriety of the Means.

          Especially in law, that is just not good.

          Please be smart enough to understand why.

          1. 5.1.1.1.1

            I was merely explaining why people always focus on 101 instead of 103…because its cheaper. Its also why SCOTUS says that 101 needs to be evaluated and used in tandem with 103 (which no case that made it there should have survived under either). Its easier and clears dockets and the system of unconstitutionally granted patents.

            1. 5.1.1.1.1.1

              Just for the record, it isn’t a law of nature that eligibility is cheaper and easier to tackle than obviousness. For example, at the EPO, defining the limit of eligibility was found to be extremely time-consuming (ie expensive) so the EPO shifted to obviousness to perform the strict filtering.

              The patent litigation community in England, of course, makes a first big meal of eligibility, than then makes just as big a meal out of obviousness question.

              The intellectual justification for the EPO fix is that eligibility should be done as an absolute filter, not one relative to the prior art as it just happened to be, one day before the date of the claim. That position has merit, despite the English “intellectually d1s h0nest” put-down of it.

            2. 5.1.1.1.1.2

              Alex,

              Your mere explanation is lacking. It comes across instead as a “use 101 in place of 103 because ‘cheaper’ -and no tie to ‘both are appropriate and use the cheaper one,”

              Your post smacks of the very conflation that Congress set to quell when it set up 103 in the first place and removed the common law power of defining invention from the judiciary.

              People – please come to the table with some minimum level of understanding history and the basics, please.

      2. 5.1.2

        Did I say anything about §103? I was clarifying a fact.

        If you really do wish to look into the relationship between §101, §102, and §103 — especially in the context of new and useful compositions of matter, I can recommend Prolegomena to Any Future Metaphysics by Kant.

      3. 5.1.3

        If they could’ve made a 103 argument, why didn’t they?

        I’m pretty sure that 103 arguments were made by the accused infringer here. They were either poorly made or they got buried under an avalanche of irrelevant or innacurate testimony, or both.

        Don’t forget that the claims that Prometheus was asserting were also plainly obvious but “mysteriously” made it through the system.

        I’ll also note here that some of the mythology surrounding this claimed “innovation” refuses to quit. For instance, Dennis writes “the invention at issue here solves a very practical problem accessing fetal DNA without creating a major health risk for the unborn child.”

        Note first that the prior art taught methods that didn’t create “major health risks” for the unborn child, i.e, it taught that fetal cells could be isolated from the mother’s serum and the DNA could be detected in those cells. Second, amniocentesis is not considered a “major health risk for unborn children”. Yes, there is a small risk of to the fetus and the woman pretty much anytime you start probing a pregnant woman’s private parts because (surprise!) that’s how infections and other accidents happen. Of course, depending on what state you live in, your religious-minded government may require you to get probed whether you like it or not.

    2. 5.2

      Thanks for that added fact. It could have affected the outcome at different stages, but at this point, it’s academic to the issue of how/whether discoveries of nature should be claimable.

      1. 5.2.1

        but at this point, it’s academic

        Therein lies the shame of “well, we can’t do anything about it.”

        Pure B$.

        That type of defeatist attitude shouldnever be allowed to become self-fulfilling.

  12. 3

    PB: It appears from the snippets given above that everyone agreed this was patentable

    I didn’t choose which snippets to publish. Dennis did. Read the opinion and you’ll find that there is little love for the claims at issue.

    which doctors were being trolled in this case?

    I don’t know. I didn’t say that any doctors were being tr0lled in this case but it seems to me that if the patent was ever asserted against the folks who discovered fetal cells in maternal blood that would be a sad miscarriage of justice.

    The point — as is typically the case with subject matter eligibility issues — is bigger than “this case.” The point is that when we allow people who discover a natural phenomenon to patent “look at this phenomenon using [insert generically described conventional technique here]”, the system explodes with applicants doing just that and little more. That’s what had already begun happening. This case helps to clear the deck.

    1. 3.2

      The point is that when we allow people who discover a natural phenomenon to patent “look at this phenomenon using [insert generically described conventional technique here]”, the system explodes with people discovering useful natural phenomena.

      The difference between normal cells and cancer cells is a natural phenomena. Targeting cancer cells with a drug using that natural phenomena, once it is discovered, will likely use a conventional technique adapted according to that natural phenomenal (like increased carbohydrate uptake). That’s just the sort of discovery the Constitution wanted to promote when it authorized securing for limited times to inventors the exclusive right to their respective DISCOVERIES.

      What else is there to discover but natural phenomena and laws of nature?

      1. 3.2.1

        I hope everybody noticed that while one of the concurrences noted that “some amici” had suggested that no diagnostic method was patentable anymore, the Federal Circuit plainly refused to buy the “argument”. That’s because it’s a specious argument.

        The difference between normal cells and cancer cells is a natural phenomena.

        Indeed. That’s why if I “discover” a naturally occuring cancer cell that was previously undescribed I can’t claim “identify [insert name of cell] and think about it’s cancerous nature”. I also can’t claim “identify [insert name of cell] using generic pre-existing process for distinguishing between cells.” That’s what this case is about.

        Targeting cancer cells with a drug using that natural phenomena, once it is discovered, will likely use a conventional technique adapted according to that natural phenomenal (like increased carbohydrate uptake).

        Why would any society want to hand out patents on using conventional techniques to look at naturally occuring phenomenona or using conventional drugs for their known purposes (e.g., “reducing cancerous cell division”)?

        It’s a serious question. It’s not as if there aren’t other proven successful ways to promote basic medical research (e.g., identifying cancer cells). This gets back to the fundamental problem of taking useful tools out of the public’s hands and burdening them with a zillion patent claims. PCR, for example, is a useful tool and it’s most definitely in the public domain. Everybody knows what it’s for and how it works. Why we would want the use of PCR to detect some patent ineligible natural phenomenon of the exact class for which PCR was invented to detect to be taken out of the public domain and given “exclusively” to some private entity?

        We have a variety of restrictions on patentability for a variety of reasons. Every one of those restrictions prevents some class of would-be patent applicants from obtaining some kind of patent protection and, thus, everyone one of those restrictions arguably makes it “more difficult” to obtain funding in that class of endeavor. Obviousness is perhaps the quintessential example. Shouldn’t we get rid of obviousness if the over-riding issue is always going to be “it’ll be harder for companies doing that obvious stuff to compete against other companies doing that obvious stuff”? That kind of argument strikes me as very weak sauce but it keeps showing up whenever some group finds itself operating on the extreme fringes of the system.

        Patents are awesome and powerful tools but they aren’t the answer to everything. In some cases — broadly claimed diagnostic methods (as here) and narrowly claimed diagnostic information (as in Mayo) being two classic examples — they can easily become a bigger problem in themselves than the problem of “how do we promote progress.”

        1. 3.2.1.1

          “Why would any society want to hand out patents on using conventional techniques to look at naturally occuring phenomenona or using conventional drugs for their known purposes (e.g., “reducing cancerous cell division”)?”

          To promote progress in curing cancer of course.

      2. 3.2.2

        Les: What else is there to discover but natural phenomena and laws of nature?

        What else? How about inventive, patent eligible applications of those ineligible discoveries?

        That’s what the Supremes were driving at in Myriad. The patentee here was in prime position to come up with that “something more” and (this can’t be stated enough) put that “something more” in the claims. That “something more” would be (for example) a specifically tailored process whose recited details would not have been obvious to a skilled artisan presented with the (ineligible) description of the pre-existing phenomenon.

          1. 3.2.2.1.1

            Just to tweak Les for a moment…

            35 USC 100(a): The term “invention” means invention or discovery.

            I’ll let this sink in before I add something more pleasing to Les.

              1. 3.2.2.1.1.1.1

                Sure, not in a one to one correspondence, but it does throw a bucket of cold water on your direct statement of 3.2.2.1, where you try to differentiate discovery and inventions in the patent sense.

                That more pleasing aspect I mentioned….:

                BOTH discoveries and inventions (no matter how you may want to distinguish them) appear to have been included by the writers of patent law to be included as belonging to patent law.

  13. 2

    In the 3 1/2 years since the Mayo decision, the diagnostic industry has not been able to get a bill even proposed in Congress that would so-tailor these rules (at least that I know of).

    The last four years have been characterized by patent reform fever – the AIA, calls to rein in E.D. Tex., “real party in interest,” propping up the PTAB, etc.

    But after several years of concerted momentum, the latter six months have been characterized by a palpable shift. We’re seeing more frequent expressions of hesitance, regret, and calls for nuance or balance are issuing – not just from patentees and applicants, but from the USPTO (the July Update to the Interim Guidance); district courts (which are, collectively, at the forefront of identifying patent-eligible subject matter); and the Federal Circuit (as seen here).

    2016 will certainly be an interesting year for this area!

    1. 2.1

      I’ll say this much here (with more specific thoughts later): while I’m not on completely on board with any of the written aspects of this en banc denial, the discussion of subject matter eligibility generally is an order of magnitude more thoughtful and informed than it was in the Metabolite Lab era.

      1. 2.1.1

        That’s not saying much Malcolm.

        In fact, it sounds more like not saying anything. Rather non-committal about what you are – and are not – “on board” with. Rather empty in what portion is more thoughtful and informed over Metabolite (and why).

        Let me guess: because you feel that way…?

  14. 1

    DC: The big idea was the hypothesis that fetal DNA might be floating around in the mother’s blood and that the fetal DNA

    The prior art taught that there were fetal cells floating around in the mother’s blood. Given that, the hypothesis that fetal DNA is in the blood, too, was not a “big idea.” On the contrary, the existence of fetal DNA in the maternal blood is pretty much a given once you find fetal cells there. The only question is exactly what processing steps and amplification conditions are necessary to obtain accurate results (minimizing false positives and negatives) in a reproducible and/or commercially viable manner.

    [the fetal DNA] could be selectively amplified by focusing on the paternally inherited portion of its DNA (rather than the maternally inherited).

    Choosing unique primer sequences to selectively amplify DNA from a mixed population was old as the hills when the application was filed. Again, the real problem for diagnosticians is determining the primer sequences and conditions that provide reproducible results. The solution to that problem does not appear in Ariosa’s claims and that’s why the claims are doomed.

    Perhaps the most interesting and important part of the concurrences here is that the judges aren’t shying away from experiencing their views about the problem(s) with the asserted claims generally. But they don’t like them and Ariosa can rest assured that even if there wasn’t a 101 issue (and there surely is) those claims would not be enforceable for long. Myriad’s claims had similar problems (even worse), as everyone will remember, and — similarly — those problems were mostly glossed over by the folks who were so terribly concerned about what would happen “if we don’t allow these innovations [sic] to be patented.”

    The answer to the question is “what will happen” is that there will be waaaaay less junky patents out there and diagnosticians and doctors will be able to do their jobs without being tr0lled.

    1. 1.1

      And which doctors were being trolled in this case? Also, I thought a “patent troll” was someone who only owned patents but did not own the technology. Was that the case here?

      It appears from the snippets given above that everyone agreed this was patentable (save maybe you), but no one could go against Supreme Court precedent. That doesn’t sound like a ringing endorsement of the SC’s caselaw.

        1. 1.1.1.1

          Patent eligible in China, Australia, Canada, and Europe.

          But not the US.

          So much for patent harmonization…..

          1. 1.1.1.1.1

            England and the EPO have the identical 101, 102 and 103 statutory provisions. Yet one (the EPO) does the filtering under 103 while the UK (like the USA, These days) attempts a rigorous filter at the 101 eligibility stage.

            So “eligible” at the EPO is trivial. What counts there are the other statutory provisions. So when you write “Europe” can you be more specific.

            Further, MM points out that the features that render the subject matter fit for patent are absent from the claims at issue in this US case. The EPO is quite hot on this aspect of exam on the merits. Unless I know what features were in the claims issued in “Europe” I cannot judge whether there is any disharmony.

            1. 1.1.1.1.1.1

              features that render the subject matter fit for patent are absent

              I missed that in his rather conclusory post. Can you be explicit about this?

              1. 1.1.1.1.1.1.1

                Repeated: PCR is a tool whose purpose is to amplify small amounts of DNA such that they can detected or further manipulated. The “small amounts of DNA” includes specific DNA molecules of interest floating around in a sea of less interesting but more abundant DNA molecules.

                That PCR can detect incredibly small numbers of molecules was a very well-known fact as of the critical date of this invention. For a diagnostic method, the trick — the skill — is to identify the specific primers and reaction conditions and isolation methods that lead to a reproducible result. None of that is in the claim.

                By analogy to the telescope analogy we’ve discussed here previously, it’s as if the inventors discovered an asteroid and wanted to have exlusive rights to study the asteroid. So they name the asteroid and they claim a method reciting “Use a telescope to look at [insert asteroid name here].” They don’t even recite how to find the asteroid in the sky. No coordinates, nothing. Maybe to make it look a bit more “technical” they throw in a another limitation about “focusing the telescope”.

                It’s a d.o.a. claim (or should be — it certainly is now).

          2. 1.1.1.1.2

            I am not so sure this case would be patentable in Australia. Myriad was recently knocked out here and our courts have expressed a strong preference to follow the US Supreme Court over any other authorities.
            I fear Australia would have the same disastrous consequences in this case…

      1. 1.1.2

        Eh, the claims have serious 103 issues as well. Perhaps the “invention” was nonobvious, but the representative claims in no way seem to indicate that.

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